Effect of a substance P antagonist on aldosterone secretion in patients with obstructive sleep apnea and hypertension

PILOT STUDY OF THE EFFECT OF A SUBSTANCE P ANTAGONIST, APREPITANT, ON THE SECRETION OF ALDOSTERONE IN PATIENTS WITH OBSTRUCTIVE SLEEP APNEA SYNDROME AND ARTERIAL HYPERTENSION

This study is testing if a new medication can help lower a hormone linked to high blood pressure in people with sleep apnea and hypertension.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 24 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: University Hospital, Rouen (Academic / other)
• Locations: 1 site (Rouen, France)
• Trial ID: NCT06462287 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the impact of a substance P antagonist, Aprepitant, on aldosterone secretion in patients suffering from obstructive sleep apnea syndrome (OSAS) and arterial hypertension. The study aims to understand the relationship between hyperaldosteronism and cardiovascular complications in these patients, particularly focusing on how obesity and metabolic syndrome may influence aldosterone levels. Participants will be randomly assigned to receive either the active drug or a placebo, with careful monitoring of their blood pressure and sleep apnea symptoms throughout the trial.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 to 75 with severe obstructive sleep apnea and essential hypertension.

Not a fit: Patients under 18 or over 75 years old, or those with certain contraindicated conditions, may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved management of hypertension in patients with obstructive sleep apnea, potentially reducing cardiovascular risks.

How similar studies have performed: While the specific approach of using a substance P antagonist in this context is novel, related studies have shown potential benefits of targeting aldosterone in similar patient populations.

Eligibility criteria

Inclusion Criteria:

1. Subject with severe obstructive sleep apnea syndrome (OSAS) defined by an apnea and hypopnea index (AHI) ≥ 30/h on polysomnography or ventilatory polygraphy (requiring continuous positive airway pressure).
2. Subject with essential hypertension treated medically or by lifestyle and dietary measures or newly diagnosed (defined by SBP ≥ 140 and/or DBP ≥ 90 mmHg according to current SFHTA-HAS recommendations).
3. Patient's agreement to replace diuretics with another neutral antihypertensive treatment (which does not interfere with the renin-angiotensin system), to stop consuming licorice and its derivatives, 7 to 10 days before taking the treatment. experimental and throughout the study (if applicable)

Exclusion Criteria:

1. Minor subject or subject aged over 75 years
2. Criteria relating to associated pathologies leading to particular risks:

   * Subject presenting excessive daytime sleepiness with contraindication to driving (Epworth score \> 16)
   * Uncontrolled severe cardiovascular disease: myocardial infarction or stroke in the last 6 months, unstable angina, significant valvular heart disease, heart failure (≥ class II of the NYHA classification), uncontrolled cardiac arrhythmia or significant conduction abnormalities. Knowledge of chronic renal insufficiency defined by a glomerular filtration rate \< 60 mL/min/1.73m2 for more than 3 months) or moderate hepatic insufficiency defined by ALT and/or AST transaminases \> 3N)
   * Epilepsy
   * Known acute infections linked to HIV, HBV or HCV
   * Active cancer currently being treated
3. Contraindications to placebo and aprepitant

Where this trial is running

Rouen, France

• CHU de Rouen — Rouen, France, France (Recruiting)

Study contacts

• Study coordinator: Antoine-Guy Lopez

Conditions Apnea, Obstructive